Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K020067 |
Device Name |
GYRUS ENT SOMNOPLASTY GENERATOR |
Applicant |
GYRUS ENT L.L.C. |
2925 APPLING RD. |
BARTLETT,
TN
38133
|
|
Applicant Contact |
JEFFREY W COBB |
Correspondent |
GYRUS ENT L.L.C. |
2925 APPLING RD. |
BARTLETT,
TN
38133
|
|
Correspondent Contact |
JEFFREY W COBB |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 01/09/2002 |
Decision Date | 04/04/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|